NCT03026738

Brief Summary

Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of operative time, intraoperative blood loss , intraoperative organ injury, overall length of hospital stay, recurrence,and improvement of incontinence and constipation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 20, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

January 14, 2017

Last Update Submit

January 19, 2017

Conditions

Rectal Prolapse

Outcome Measures

Primary Outcomes (2)

  • improvement of incontinence and / or constipation.

    1 year postoperatively

  • recurrence rate

    1 year postoperatively

Secondary Outcomes (2)

  • Duration of Surgery

    intraoperative

  • Peri-operative blood loss

    during surgery, 1 day

Study Arms (2)

Laparoscopic anterior mesh rectopexy

EXPERIMENTAL

A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.

Procedure: Laparoscopic anterior mesh rectopexyDevice: polypropylene mesh

Laparoscopic posterior mesh rectopexy

ACTIVE COMPARATOR

Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.

Procedure: Laparoscopic posterior mesh rectopexyDevice: polypropylene mesh

Interventions

Laparoscopic anterior mesh rectopexyPROCEDURE

fixation of the rectum anteriorly using laparosopy and polypropylene mesh

Laparoscopic anterior mesh rectopexy
Laparoscopic posterior mesh rectopexyPROCEDURE

fixation of the rectum posteriorly using laparosopy and polypropylene mesh

Laparoscopic posterior mesh rectopexy
polypropylene meshDEVICE

A strip of polypropylene mesh will be introduced and sutured.

Laparoscopic anterior mesh rectopexyLaparoscopic posterior mesh rectopexy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients with rectal prolapse either external or internal prolapse

You may not qualify if:

  • Age below 18 years.
  • Pregnancy or breast-feeding.
  • Recurrence of rectal prolapse.
  • patients with previous complicated abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

January 14, 2017

First Posted

January 20, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

January 20, 2017

Record last verified: 2017-01